PRODUCT & PACKAGE TESTING VIBRATION & SHOCK
Dec 2015
Herb Schueneman Chairman, WESTPAK, Inc.
RIVETING REVISIONS OF MEDICAL PRODUCT PACKAGE TEST PROCEDURES
Katie Tran Laboratory Manager
WESTPAK, INC. June 2016
PRODUCT & PACKAGE TESTING VIBRATION & SHOCK
Dec 2015
Herb Schueneman Chairman, WESTPAK, Inc.
RIVETING REVISIONS OF MEDICAL PRODUCT PACKAGE TEST PROCEDURES
Katie Tran Laboratory Manager
WESTPAK, INC. June 2016
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Agenda
• ISO 11607 • Popular Test Methods (ISO 11607 Part 1 – Annex B) • ASTM F1929
– Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F3039 – Standard Test Method for Detecting Leaks in Nonporous Packaging or
Flexible Barrier Materials by Dye Penetration
• ASTM D642 – Standard Test Method for Determining Compressive Resistance of
Shipping Containers, Components, and Unit Loads
• ASTM F88 – Standard Test Method for Seal Strength of Flexible Barrier Materials
What is ISO 11607?
• Guidance document for validating terminally sterilized medical devices
• Recognized by FDA
• If you have a sterilized medical device, which must perform efficiently, safely, and effectively in the hands of the users.
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ISO 11607
• Packaging for terminally sterilized medical devices
– Part 1
• Requirements for materials, sterile barrier systems and packaging systems
– Part 2
• Validation requirements for forming, sealing and assembly process
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Popular Test Methods
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ISO 11607 Part 1 – Annex B Annex B
Accelerated Aging
Conditioning
Integrity
Internal Pressure
Performance Testing
Puncture
Seal Strength
Visual Inspections
Annex B - Integrity
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• Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929)
• What is porous?
– Tyvek®/paper
ASTM F1929 – Scope
• To detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 inch) wire in package edge seals formed between a transparent material and a porous sheet
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• 2015 - Released March 2016
• 2012
• 1998 (2004)
• 1998
ASTM F1929 – Revision History
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ASTM F1929 – 2015
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Previous Revision
2012
Changes 1. No changes to testing procedure
Questions?
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Annex B - Integrity
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• Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration (ASTM F3039)
• What is nonporous?
– Tray (thermoformed tray with foil/poly lid)
– Pouch (foil/foil, poly/poly)
ASTM F3039 – Scope
• To detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 inch) wire in the edge seals of a nonporous package
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• 2015 - Released March 2016
• 2013
ASTM F3039 – Revision History
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ASTM F3039 – 2015
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Previous Revision
2013
Changes 1. Labeled Method A for channels or leaks in seals 2. Added another method for testing (Method B) 3. Method B - To detect and locate a leak equal to
or greater than 10 µm (0.00039 inch) diameter in a nonporous flat sheet (checking area of interest)
ASTM F3039 – 2015 (cont.)
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2013
ASTM F3039 – 2015 (cont.)
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2013
ASTM F3039 – 2015 (cont.)
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2015
Questions?
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Annex B - Performance Testing
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• ASTM D4169
• Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads (ASTM D642)
• Vehicle Stacking
• Compression
ASTM D642 – Scope
• To measure the ability of the container to resist external compressive loads applied to its faces, to diagonally opposite edges or to corners
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• 2015 - Released June 2015
• 2000 (2010)
• 2000 (2005)e1
• 2000 (2005)
• 2000 Initial Release
ASTM D642 – Revision History
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ASTM D642 – 2015
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Previous Revision
2000
Changes 1. Recommend ASTM D4332 for transit simulation testing 2. Recommend ASTM D685 for quantification of box compression strength
ASTM D642 – 2015 (cont.)
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2000
ASTM D642 – 2015 (cont.)
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2015
ASTM D642 – 2015 (cont.)
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Introduced another standard
ASTM D685 – Scope
• Defines the standard atmospheres for normal preconditioning, conditioning, and testing of paper and paper products, paperboard, fiberboard, and containers made from them
• Specifics procedures for handling these materials in order that they may reach equilibrium with the respective atmosphere
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ASTM D685 – Revision History
• 1993 (2002)
• 1993 (1998)
• 1993 Initial Release
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Questions?
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Annex B - Seal Strength
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• Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88)
ASTM F88 – Scope
• To measure the strength of seals in flexible barrier materials
• Definition of flexible: a material with flexural strength and thickness permitting a turn back at an approximate 180 degree angle – Trays with Tyvek® lid
– Pouches
• Applicable on seals between a flexible material and a rigid material
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• 2015 – Released January 2016
• 2009
• 2007a
• 2007
• 2006
• 2005
• 2000
ASTM F88 – Revision History
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ASTM F88 – 2015
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Previous Revision
2009
Changes 1. Updated verbiage for report section
ASTM F88 – 2015 (cont.)
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2009
ASTM F88 – 2015 (cont.)
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2015
Conclusions
• ASTM F88-15 (seal strength / peel)
• ASTM F1929-15 (dye penetration – porous)
• ASTM F3039-15 (dye penetration – nonporous)
• ASTM D642-15 (vehicle stacking / compression)
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Previous Webinar Recap
• ASTM D4332-14
• ASTM D4169-14
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http://www.westpak.com/page/resources/webinars WESTPAK’s webinars link
Questions?
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About WESTPAK, INC.
Two Locations:
San Jose Laboratory San Diego Laboratory
83 Great Oaks Boulevard 10326 Roselle Street
San Jose, CA 95119 San Diego, CA 92121
408-224-1300 858-623-8100
http://www.westpak.com
Contact Us
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THANK YOU !
Please Contact Us with any questions or testing assistance needs. We are here to help you!
Katie Tran Laboratory Manager
WESTPAK, INC.
